Phase 3 data on the safety and efficacy of Omontys (peginesatide) Injection were published in the Jan. 24 issue of the New England Journal of Medicine. These studies, known as EMERALD 1 and 2, compared Omontys given to adult chronic kidney disease patients on hemodialysis once monthly to epoetin administered one-to-three times per week. The EMERALD studies were part of the new drug application upon which the U.S. Food and Drug Administration's March 27, 2012 approval of Omontys was based.
The efficacy and cardiovascular safety assessment data published in NEJM showed:
-Noninferiority to Epoetin in maintenance of hemoglobin (Hb): The difference between the Omontys and epoetin-treated groups in the mean change in Hgb levels from baseline to the study evaluation period (calculated as the mean of all measurements during weeks 29-36) in EMERALD 1 and 2 was -0.15 g/dL (95% CI: -0.30, -0.01) and 0.10 g/dL (95% CI: -0.05, 0.26) respectively.
-Similar cardiovascular safety in hemodialysis population: In the EMERALD studies, 22.8% of Omontys patients experienced one of the composite cardiovascular events, compared to 24.4% of epoetin patients (hazard ratio for the cardiovascular composite safety endpoint was 0.95 (0.77, 1.17) (95% CI)). Omontys is not indicated in patients with CKD not on dialysis. These patients experienced increased specific cardiovascular events.
"The EMERALD results are important because they not only evaluated the efficacy of Omontys and epoetin; they also represent data from the first studies to prospectively compare the cardiovascular safety of different erythropoiesis-stimulating agents for the treatment of anemia in dialysis patients with CKD," said Steven Fishbane, MD, Professor of Medicine, Hofstra North Shore-Long Island Jewish School of Medicine, lead author of the NEJM publication, and principal investigator for the EMERALD studies. "The EMERALD data demonstrated that Omontys administered once a month has a similar efficacy and cardiovascula